FDA Label for Exoten-c

View Indications, Usage & Precautions

Exoten-c Product Label

The following document was submitted to the FDA by the labeler of this product Asclemed Usa, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients



Methyl Salcylate 20.000%

Menthol 10.00%

Capsalcin 0.025%


Purpose



Topical Analgesic

Topical Analgesic

Topical Analgesic


Indications



For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.


Warnings



For external use only. Avoid contact with eyes.


Otc - Ask Doctor



If symptoms persist for more than seven days, discontinue use and consult physician.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, consult physician.


Otc - Do Not Use



Do not apply to wounds or damaged skin. Do not bandage tightly.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast feeding, contact physician prior to use.


Directions



Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.

Children under two-years of age consult a physician.


Additional Information



Store at room temperature.


Other Ingredients



Aloe Barbadensis Leaf (Aloe Vera Gel); Aqua (Deionized Water); Arnica Montana Flower Extract; Carmober, Cetearyl Alcohol, Ethylexyl Palmitate, Glyceryl Stearate, Methylisothiazolinone, PEG-100 Stearate, Tocopheryl Acetate (Vitamin E), Triethanolamine.


Principal Display Panel - Exoten-C Label



Exoten-C

Pain Relief 
Lotion

113.4 g

Distributed by Enovachem™

PHARMACEUTICALS

Torrance, CA 90501

(310) 320-0100


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